Otc - Active Ingredient
Lidocaine 4%
Numbing Creams Cream
FDA Label NDC 85881-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yongchun Lihui Trading Co., Ltd. for the product Numbing Creams (NDC 85881-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, inactive ingredient, indications & usage, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For the temporary alleviation of localized discomfort,pruritus, pain, or burning sens.
ation in the perianal area associated withanorectal disorders.
Warnings
Warnings For external use only.
Otc - Keep Out Of Reach Of Children
Safetyinformation Keep out of reach of children.if ingested, seek medical attention immediately. Do not use if you have allergiesto any of the ingredients.m if you are pregnant or breastfeeding consult a healthcareprovider before use.
Inactive Ingredient
Inactive Ingredients:Tocopheryl Acetate, Emu Oil, Propylene Glycol, Arica, Glycerin,MentholAesculus Hippocastanum (Horse Chestnut) Extract,Lecithin (Soybean),Curcuma Longa Extract, Aqua.
Indications & Usage
DirectionsClean the affected area with mild soap andwarm water, then rinse thoroughly andpat dry. For adults and children over 12 years old:Apply externally to the affected a-rea up to 4 timesa day. For children under 12 years: Consult adoctor before use.Using Finger Cots: Roll a fnger cot over your fnger.Apply a small amount of creamonto the fngertip.Evenly spread a thin layer of the cream over the skin.
Otc - Stop Use
Discontinue use and consult a doctor if:Your condition worsens or does not improve within 7 days ou exper-ience anallergicreaction to any ingredient in this product.Symptoms persist, or redness.irritation, swellingor pain intensifes Symptoms improve but return after a few days.
Dosage & Administration
Apply externally to the affected a-rea up to 4 timesa day
* Please review the disclaimer below.
